Dacron or ePTFE for Femoro-popliteal Above-Knee Bypass Grafting: Short- and Long-term Results of a Multicentre Randomised Trial

Abstract

Objectives: To compare expanded polytetrafluoroethylene (ePTFE) prosthesis and collagen-impregnated knitted polyester (Dacron) for above-knee (AK) femoro-popliteal bypass grafts. Design: A prospective multicentre randomised clinical trial. Patients and Methods: Between 1992 and 1996, 228 AK femoro-popliteal bypass grafts were randomly allocated to either an ePTFE (n = 114) or a Dacron (n = 114) vascular graft (6 mm in diameter). Patients were eligible for inclusion if presenting with disabling claudication, rest pain or tissue loss. Follow-up was performed and included clinical examination and duplex ultrasonography at all scheduled intervals. All patients were treated with warfarin. The main end-point of this study was primary patency of the bypass graft at 2, 5 and 10 years after implantation. Secondary end-points were mortality, primary assisted patency and secondary patency. Cumulative patency rates were calculated with life-table analysis and with log-rank test. Results: After 5 years, the primary, primary assisted and secondary patency rates were 36% (confidence interval (CI): 26–46%), 46% (CI: 36–56%) and 51% (CI: 41–61%) for ePTFE and 52% (CI: 42–62%) (p = 0.04), 66% (CI: 56–76%) (p = 0.01) and 70% (CI: 60–80%) (p = 0.01) for Dacron, respectively. After ten years these rates were respectively 28% (CI:18-38%), 31% (CI:19-43%) and 35% (CI: 23-47%) for ePTFE and 28% (CI: 18-38%), 49% (CI: 37-61%) and 49% (CI: 37-61%) for Dacron. Conclusion: During prolonged follow-up (10 years), Dacron femoro-popliteal bypass grafts have superior patency compared to those of ePTFE grafts. Dacron is the graft material of choice if the saphenous vein is not available.